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[SUMMARY OF PRODUCT]
Influenza HA vaccine Kovax is the influenza HA vaccine prepared through inoculating influenza virus strain into allantoic cavity of embryonated egg and then, harvesting, purifying hemagglutinin only, which is essential for immunity induction and finally inactivating with formaldehyde. It is transparent or somewhat whitish liquid preparation.

[COMPOSITION]
1 mL basis:
Active ingredient:

[APPEARENCE]
Transparent or slightly whitish liquid preparation.

[INDICATION]
Prevention of Influenza

[POSOLOGY and METHOD OF ADMINISTRATION]
At first year, administer by intramuscular injection with the volume below, and then if sub-strains are not changed in the subsequent year administer the same dose once a year.
1) Children of 6-35 months: one dose of 0.25 mL and then, administer one dose more after an interval of at least one week.
2) Children of 3-8 years: one dose of 0.5 mL and then, administer one dose more after an interval of at least 4 weeks.
3) Children from 9 years and Adults: one dose 0.5 mL dose

[PRECAUTIONS FOR USE]
1. Contraindications
Prior to administration, check health status of the subject by inquiry and general inspection, and auscultation of percussion if necessary. Persons who meet the following criteria should not be immunized. However, in case that ther are high-risk group of infection and immunization would give much benefit, then they could be immunized under care.
1) Fever or severe dystrophy
2) Cardiovascular, renal or liver disease in acute, exacerbating or active phase.
3) Acute respiratory disorder or other active infection
4) Latency or convalescence
5) History or anaphylaxis to the components of the product
6) Hypersensitive to egg, chicken or other chicken-derived components.
7) History of abnormal adverse reactions after vaccination or suspected allergic reactions including systemic eruption.
9) Convulsion within 1 year before vaccination
10) Severe neurologic disorders
11) Diagnosed of immune disorder
12) Other inappropriate conditions for immunization
13) Persons who are hypersensitive to thimersal

2. Special Precautions
1) Pregnancy or possible pregnancy
2) Cardiovascular disease, respiratory disorder and diabetes; these disease can be exarcerbated if the patient gets infected by influenza.

3. Adverse Reaction
1) Local reactions including rash, swelling and ache or systemic reactions including fever, chill, headache, malaise and vomiting may occur, which generally disappear within 2 or 3 days.
2) Encephalomyelitis: Acute disseminated encephalomyelitis (ADEM) may occur rarely. Signs include fever, headache, convulsion, dyscinesia and disturbance of consciousness, etc., which generally occur within several days through 2 weeks after vaccination. In case any suspicious case occurs, diagnose using MRI et. for proper treatment.
3) Very rarelly, allergic reaction or anaphylaxis shock may occur.
4) Transient impairment in systemic or local nerve tissue network, or paraethesia to irritation or pain may occur. Paralysis, neuralgia, vasculitis inducing hemorrhage or encephalitis or neuritis (ex. Guillian-Barre syndrome) have been reported.
5) This drug may cause hupersensitivity since it contains thimerosal (organic mercury formula).

4. General Precautions
1) The product should be inspected visually for abnormal turbidity, coloring and/or presence of foreign particles. In any these cases, the product should not be administrated.
2) Patients, parents or guardians should be instructed to take a rest until next day of vaccination and to keep inoculated site clean. They also should be instructed to consult doctor promptly, if high fever or convulsion, etc., occurs.

5. Use in Pregnancy
If there is an increased risk for influenza infection or influenza-related complications, pregnant women may be vaccinated after the second trimester of pregnancy. However, special care should be taken since it is not known whether it may cause fetal harm.

6. Precautions for Administration
1) Inoculating instruments should be sterilized with dry heat, autoclave ethylene oxide gas or cobalt 60-radiated y-ray and coolded down to room temperature before use.
2) Aseptically cleanse the rubber stopper and the circumference with alcohol, then insert the needle through the stopper and draw the administrating volume. Operation should be carefully conducted, not to contaminate the vial with bacteria.
3) Reconstitute the vial just prior to administration, and use promptly upon reconstitution.
4) Usually the preferred injection site is the lateral aspect of the upper arms. It should be cleansed with alcohol or iodine tincture. Do not inject at the same site repeatedly.
5) Be sure that the needle tip does not enter the blood vessel.
6) A new needle should be used for every patient.

7. Precautions for Storage.
1) Do not use a frozen product, whose quality may deteriorate.
2) The product should be brought into room temperature and shaken well before use.
3) Once opened, the product should be used during that day.

8. Other.
Name of strains used and the unit should be specified in packaging.

[STORAGE CONDITION]
Between 2ºC and 8ºC, protected from light in hermetic container. Do not freeze.

I'm a certified Translator, member of OMT (Mexican Translators Organisation) and the FIT, among other International Organisations.

I have lived and worked in UK for the past 7 years, which allows me to experience a total immersion into English culture. I have dual citizenship, Mexican and British.

I obtained an International Business Bachelor's Degree and a Bachelor's Degree in Marketing, Public Relations and Advertising, both at Universidad of Guadalajara. I studied a Comparative Political Studies Postgraduate Degree at King's College London. Currently I'm studying a MBA at SMARTLY, I'm also a student at the WIPO Worldwide Academy Distant Learning Program. I recently obtained there a Diploma in Intellectual Property and at present, I'm studying to obtain another Diploma in Copyright and Related Rights, E-Commerce, Traditional Knowledge and Biotechnology.

I worked as the Head Officer of the Procurement, Tendering, International Business and Logistics Department of a Mexican Pharmaceutical Laboratory (Grupo Carbel, S.A. de C.V.) for 7 years, which provided me with all the experience I have in the Pharmaceutical, Medical, Regulatory, Licensing (Patents) and Drug's Registration fields.

I have worked as translator, proof-reader and style editor with international companies such as Boehringer-Ingelheim (Boehringer Vetmedica) and as well with small laboratories, like Halvet Laboratorios, S.A. de C.V., since 2000. Lately I have been working closely with the Mexican Health Department (COFEPRIS) in order to update all the DMF's of my regular clients based in Mexico for the new HD's registration platform.

Due to my working experience and training, I have a solid background in Business Development and Management, Finance, Corporate Identity and Image, Advertising, Publishing and Marketing as well; although Healthcare, Medical and Pharmaceutical are my primary fields and preferred terminologies, mostly working with pharmaceutical companies in Mexico, Brazil, Argentina, China, France, Italy, India and USA.